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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000024942 |
Receipt No. | R000028694 |
Scientific Title | Venous Thromboembolism (VTE) in Cancer Patients;a Multicenter Prospective Registry |
Date of disclosure of the study information | 2017/02/10 |
Last modified on | 2019/01/29 |
Basic information | ||
Public title | Venous Thromboembolism (VTE) in Cancer Patients;a Multicenter Prospective Registry | |
Acronym | Cancer-VTE Registry | |
Scientific Title | Venous Thromboembolism (VTE) in Cancer Patients;a Multicenter Prospective Registry | |
Scientific Title:Acronym | Cancer-VTE Registry | |
Region |
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Condition | ||||||||||
Condition | colon cancer, lung cancer, gastric cancer, breast cancer, gynecologic cancer, pancreatic cancer | |||||||||
Classification by specialty |
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Classification by malignancy | Malignancy | |||||||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study is intended to clarify the frequency of intercurrent of venous thromboembolism (VTE), actual condition of VTE treatment and its prognosis and to identify background factor related with VTE events in cancer patients, in addition clarify optimal medical attention population and usage for Direct Oral Anti Coagulant (DOAC) treatment. |
Basic objectives2 | Others |
Basic objectives -Others | Evaluate a variety of clinical questions between cancer and VTE |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | (1) Baseline
frequency of intercurrent of VTE at the time of VTE screening (2) Observation period (one year) incidence of symptomatic VTE incidence of bleeding events |
Key secondary outcomes | Incidence of brain infarction/ systemic embolism
Survival VTE related mortality rate and bleeding related mortality rate Brain infarction related mortality rate and systemic embolism related mortality rate |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
Interventions/Control_3 | |
Interventions/Control_4 | |
Interventions/Control_5 | |
Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1)20 years old or older at written informed consent.
(2) Diagnosed with any one of the following: colorectal cancer, lung cancer (small cell lung cancer, and non-small cell lung cancer), gastric cancer, breast cancer, gynecological cancer (endmetrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and peritoneal cancer), or pancreatic cancer (both initial and/or recurrence). Except active double cancer (synchronous double cancer, and metachronous double cancer with a disease-free period within 5 years) patients but patients with intramucosal cancer can be enrolled. (3) Planned to undergo drug therapy (chemotherapy, hormone therapy, targeted molecular therapy, and immune checkpoint inhibitor therapy), radiation therapy or surgery. For recurrence cases, patients who received drug therapy (chemotherapy, hormone therapy, targeted molecular therapy, and immune checkpoint inhibitor therapy), radiation therapy or underwent surgery at initial occurrence can be enrolled. (4) Carried out VTE screening (lower extremities venous ultrasound) within 2 months before enrollment and before the cancer treatment. If D-dimer value after the diagnosis of cancer is <=1.2 microgram/mL, VTE screening is not required. (5) Stage II to IV; for gynecological cancer, Stage I to IV and for lung cancer, Stage IB to IV. (6) Expected survival after enrollment must be >=6 months; for pancreatic cancer, >=3 months. (7) Eastern Cooperative Oncology Group (ECOG) Performance Status grade must be 0-2; for pancreatic cancer, 0-1. (8) Informed consent in writing given freely by the patients themselves for participation in the survey of this study. |
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Key exclusion criteria | A patient who is inappropriate as a subject of the study judged by investigator. | |||
Target sample size | 10000 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Chuo University | ||||||
Division name | Department of science and engineering | ||||||
Zip code | |||||||
Address | 1-13-27Kasuga Bunkyoku Tokyo | ||||||
TEL | 03-3817-1715 | ||||||
ohashiy.00e@g.chuo-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | J-CRUSE | ||||||
Division name | Department of Clinical Research Promotion | ||||||
Zip code | |||||||
Address | 6-29 Ogawacho Shinjukuku Tokyo | ||||||
TEL | 03-5946-8264 | ||||||
Homepage URL | |||||||
vte@j-crsu.co.jp |
Sponsor | |
Institute | Medical Science Department
Daiichi Sankyo Company, Limited. |
Institute | |
Department |
Funding Source | |
Organization | Medical Science Department
Daiichi Sankyo Company, Limited. 3-5-1 Nihonbashi-honcho Chuo-ku, Tokyo 103-8426 |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 国立がん研究センター中央病院(東京)、国立がん研究センター東病院(千葉県)、大阪府立成人病センター(大阪)、国立病院機構大阪医療センター(大阪)、兵庫医科大学(兵庫)、日本赤十字社医療センター(東京)、埼玉医科大学国際医療センター(埼玉)他約150施設 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
Other related information | Multicenter Prospective Registry |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028694 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |